Colchicine Tablets
Definition
Colchicine Tablets contain Colchicine.
Content of colchicine, C22H25NO6
95.0 to 105.0% of the stated amount.
Identification
TESTS
Dissolution
Comply with the dissolution test for tablets and capsules, Appendix XII B1.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions protected from light.
The chromatographic conditions described under Related substances may be used. Inject 50 µL of each solution and use a detection wavelength of 243 nm.
Calculate the total content of colchicine, C22H25NO6, in the medium from the chromatograms obtained and using the declared content of C22H25NO6 in colchicine BPCRS.
The amount of colchicine released is not less than 75% (Q) of the stated amount.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in methanol (50%) protected from light.
When the chromatograms are recorded under the prescribed conditions the retention time relative to colchicine (retention time about 13 minutes) is: impurity A, about 0.9.
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between impurity A and colchicine is at least 1.5.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity A is not greater than 3.5 times the area of the principal peak in the chromatogram obtained with solution (2) (3.5%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
the sum of the areas of all of the secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (5%).
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Colchicine comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in methanol (50%) protected from light.
The chromatographic conditions described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between impurity A and colchicine is at least 1.5.
Calculate the content of C22H25NO6 in each tablet using the declared content of C22H25NO6 in colchicine BPCRS.
Assay
Use the average of the individual results determined in the test for Uniformity of content.
Impurities
The impurities limited by the requirements of this monograph include those listed under Colchicine.
Storage
Colchicine Tablets should be protected from light.